O FFICE OF S CIENCE & R ESEARCH OSR O FFICE OF S CIENCE & R ESEARCH OSR Welcome to the Research Navigator Institutional Biosafety Committee (IBC) Creation and Submission of “Agree to Participate” Updated 4/2015

O FFICE OF S CIENCE & R ESEARCH OSR In this module, you will learn how to agree to participate in an IBC submission for research involving: recombinant DNA (rDNA), infectious agents, non-human primate materials (including established cell lines), select agent studies conducted at New York University and within the NYU Langone Medical Center. This submission is known as a “registration.” Registrations are reviewed by the New York University Institutional Biosafety Committee. The IBC is responsible for providing review and oversight of these studies to ensure compliance with the NIH Guidelines and all of the Institution's policies. Registrations are submitted to the IBC through the online Research Navigator IBC module.NIH GuidelinesResearch Navigator IBC module Welcome to the Research Navigator IBC learning module for NYULMC users

O FFICE OF S CIENCE & R ESEARCH OSR Washington Square/Dental School Users Please note that in addition to your NYU NET ID, a NYU Langone Medical Center Kerberos ID (KID) and password is required to login Navigator/IBC. Refer to the “Welcome to Research Navigator Institutional Biosafety Committee (IBC) Learning Module – Access from outside of the NYU Langone Medical Center” training PowerPoint Presentation for specific instructions on how to obtain a KID.“Welcome to Research Navigator Institutional Biosafety Committee (IBC) Learning Module – Access from outside of the NYU Langone Medical Center”

O FFICE OF S CIENCE & R ESEARCH OSR Required training for IBC submissions. Environmental Health and Safety has developed a training course required for anyone submitting or participating in studies registered with the NYULMC IBC including those involving human gene transfer. This course entitled “EH&S – Recombinant DNA: Use and Safe Handling” is located on iDevelop. *** Washington Square/Dental School Users should contact for access to the rDNA training course. The NIH’s Office of Biotechnology Affairs (OBA) has issued citations to many institutions for insufficient training of rDNA users on the NIH’s rDNA Guidelines. To satisfy this requirement, training is required once every three years. If you plan to submit a registration to the IBC, you are advised to take this short 10 minute course prior to submission. If you or your study staff have not successfully completed the course at the time of IBC submission, you will be reminded of the requirement prior to IBC approval. Contact in Environmental Health & Safety if you have any questions related to the training course.

O FFICE OF S CIENCE & R ESEARCH OSR After reviewing this PowerPoint Presentation, you will be able to: Login to Research Navigator/IBC Navigate to the appropriate IBC submission which describes research that requires your participation Understand the decisions of the IBC after review Objectives

O FFICE OF S CIENCE & R ESEARCH OSR IBC registration creation process – request agree to participate Prior to submission, Study Staff listed on the registration are required to verify that they have read and understood their roles and responsibilities as described in the registration document. This step is known as "agreeing to participate." Study staff will complete this action by logging in to Research Navigator IBC and selecting the participation link located in their inbox. The PI will not be able to submit the registration until all study staff have agreed to participate.

O FFICE OF S CIENCE & R ESEARCH OSR notification of request to participate Congratulations! You have been named as Study Staff on an IBC registration. Individuals listed as Study Staff are personnel who will be performing experiments described in the submitted registration. You must “agree to participate” in the conduct of the experiments prior to submission of the registration to the IBC.

O FFICE OF S CIENCE & R ESEARCH OSR Selecting the link to access the registration Select the link to navigate to the IBC registration

O FFICE OF S CIENCE & R ESEARCH OSR Opening the registration

O FFICE OF S CIENCE & R ESEARCH OSR BEFORE you agree to participate Select to open the submission. **You must read the submission in order to understand your role and responsibilities on this submission**

O FFICE OF S CIENCE & R ESEARCH OSR Agreeing to participate

O FFICE OF S CIENCE & R ESEARCH OSR Attestation statement Select to checkbox to indicate that you have read and agree to the statement. Be sure to select “ok” to execute the agreement.

O FFICE OF S CIENCE & R ESEARCH OSR IBC registration submission process – outcome of IBC review After review by the IBC, registrations are either: Approved or Modifications are required to the registration before approval -If the modifications are satisfactory to the IBC, the registration is then approved. Recombinant DNA registrations are approved for 3 years with a requirement for an annual review submission in years 2 and 3. Human Gene Transfer registrations are approved for one year. Annual continuations and changes to an approved registration (e.g. amendments) are discussed in a separate eLearning module.

O FFICE OF S CIENCE & R ESEARCH OSR Text Slide Title IBC Contact information IBC website: IBC address: IBC Director Natalie L. Mays Research Navigator information Research Navigator IBC module: If you experience any problems using Research Navigator IBC, please report the issue by opening a ticket online using MCIT Support & Services or by contacting the MCIT Help Desk at (x36868 Internal) or (toll free).MCIT Support & Services